A WHO remit to improve global standards for medical products of human origin.

In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms.

Au cours des dernières décennies, des progrès considérables ont été réalisés pour assurer la sécurité des transfusions sanguines et des transplantations d'organes. Cependant, avec l'augmentation de la circulation de produits médicaux d'origine humaine par-delà les frontières internationales, il est impératif de renforcer la gouvernance et les normes mondiales. Ces produits, parmi lesquels figurent le sang, les organes, les tissus, les cellules, le lait maternel et le microbiote fécal, sont aujourd'hui essentiels pour les soins de santé. Mais ils comportent également des risques particuliers en raison de leur origine humaine, comme la transmission de maladies et le rejet de greffe. En outre, la demande en produits médicaux d'origine humaine dépasse souvent l'offre, ce qui engendre une dépendance vis-à-vis des chaînes d'approvisionnement internationales, tandis que des technologies émergentes telles que la thérapie cellulaire et génique posent de nouveaux défis en raison de leur efficacité non démontrée et des risques à long terme. Les mécanismes de réglementation actuels sont insuffisants, surtout dans les pays à revenu faible et intermédiaire. L'Organisation mondiale de la Santé (OMS) possède à la fois le mandat et l'expérience nécessaires pour mener le développement de normes internationales de qualité et de sécurité, d'une nomenclature cohérente des produits, ainsi que de systèmes de traçabilité et de biovigilance solides. Une approche internationale et multilatérale est cruciale pour gérer la complexité liée à l'utilisation de produits médicaux d'origine humaine dans le monde et garantir leur innocuité. Cette approche devra prévoir la mise en place de descriptions de produits uniformes, l'amélioration des systèmes de communication numériques et l'exploitation des ressources existantes afin d'aider les pays à définir des règles pour de tels produits. Comme l'illustre la résolution WHA77.4 de l'Assemblée mondiale de la Santé sur la transplantation, émise en 2024, les efforts constants de l'OMS visant à assurer la sécurité, l'efficacité et l'usage éthique des produits médicaux d'origine humaine à travers le monde représente l'occasion de stimuler la coopération internationale en matière d'établissement des normes.

En las últimas décadas, se han realizado avances considerables para garantizar la seguridad de las transfusiones de sangre y los trasplantes de órganos. Sin embargo, con el creciente movimiento de productos médicos de origen humano a través de las fronteras internacionales, es necesario reforzar las normas y la gobernanza mundiales. Estos productos, que incluyen sangre, órganos, tejidos, células, leche humana y microbiota fecal, son hoy cruciales para la asistencia sanitaria, pero también plantean riesgos únicos por su origen humano, como la transmisión de enfermedades y el fracaso de los injertos. Además, la demanda de productos médicos de origen humano suele ser superior a la oferta, lo que hace depender de las cadenas de suministro internacionales, y las tecnologías emergentes, como la terapia celular y genética, plantean nuevos desafíos debido a su eficacia no demostrada y a sus riesgos a largo plazo. Los mecanismos reguladores actuales, en especial en los países de ingresos bajos y medios, son insuficientes. La Organización Mundial de la Salud (OMS) tiene tanto el mandato como la experiencia para liderar el desarrollo de estándares internacionales de calidad y seguridad, nomenclatura coherente de productos y sistemas sólidos de trazabilidad y biovigilancia. Para responder a la complejidad del uso global de los productos médicos de origen humano y garantizar su seguridad, es fundamental un enfoque internacional que incluya a todas las partes interesadas. Este enfoque requerirá promover descripciones uniformes de los productos, reforzar los sistemas de comunicación digital y aprovechar los recursos existentes con el fin de ayudar a los países a establecer normativas para estos productos. Como se ilustra en la resolución WHA77.4 de la Asamblea Mundial de la Salud sobre trasplantes en 2024, los esfuerzos en curso de la OMS para asegurar el uso seguro, eficiente y ético de los productos médicos de origen humano en todo el mundo brindan la oportunidad de impulsar la cooperación internacional en el establecimiento de normas.

Testing of tissue specimens obtained from SARS-CoV-2 nasopharyngeal swab-positive donors.

Risk for transmission of SARS-CoV-2 through allogeneic human tissue transplantation is unknown. To further evaluate the risk of virus transmission, tissues were obtained from deceased donors who had tested positive for SARS-CoV-2 RNA via nasopharyngeal swab. This study evaluated an array of human tissues recovered for transplantation, including bone, tendon, skin, fascia lata, vascular tissues, and heart valves. Tissue samples and plasma or serum samples, if available, were tested for viral RNA (vRNA) using a real time PCR system for the presence of virus RNA. All samples were tested in quadruplicate for both subgenomic (sgRNA) and genomic (gRNA) RNA encoding the SARS-CoV-2 nucleocapsid gene. Amplification of a cellular housekeeping gene served as the positive control for every sample. A total of 47 tissue samples from 17 donors were tested for SARS-CoV-2 RNA. Four donors had plasma or serum available for paired testing. SARS-CoV-2 RNA was not detected from any tissue or plasma/serum sample tested. Based on these findings, risk of transmission through the transplantation of tissue types studied from SARS-CoV-2 infected donors is likely to be low.

Low rate of detection of SARS-CoV-2 RNA in deceased tissue donors.

Given the possibility for disease transmission, this study was performed to determine whether there is detectable SARS-CoV-2 viral RNA in the blood of deceased tissue donors. A retrospective analysis of blood samples from eligible deceased tissue donors from Oct 2019 through June 2020 was performed. Plasma aliquots were initially tested with a SARS-CoV-2 NAT Assay; positive samples were further tested using an alternate NAT and an antibody assay. The proportion of donors with confirmed RNAemia and 95% confidence intervals were computed. Of donor samples collected in 2019, 894 yielded valid results, with 6 initially positive, none of which confirmed positive by alternate NAT. Of donor samples collected in 2020, 2562 yielded valid initial NAT results, with 21 (0.8%) initially positive. Among those, 3 were confirmed by alternate NAT, 17 were not confirmed, and 1 had an invalid alternate NAT result. The rate of SARS-CoV-2 RNAemia in deceased tissue donors is approximately 1 per 1000, and it is unknown whether this RNAemia reflects the presence of infectious virus. Given these results, the risk of transmission through tissue is thought likely to be low.

Estimating incidence of infection from diverse data sources: Zika virus in Puerto Rico, 2016.

Emerging epidemics are challenging to track. Only a subset of cases is recognized and reported, as seen with the Zika virus (ZIKV) epidemic where large proportions of infection were asymptomatic. However, multiple imperfect indicators of infection provide an opportunity to estimate the underlying incidence of infection. We developed a modeling approach that integrates a generic Time-series Susceptible-Infected-Recovered epidemic model with assumptions about reporting biases in a Bayesian framework and applied it to the 2016 Zika epidemic in Puerto Rico using three indicators: suspected arboviral cases, suspected Zika-associated Guillain-Barré Syndrome cases, and blood bank data. Using this combination of surveillance data, we estimated the peak of the epidemic occurred during the week of August 15, 2016 (the 33rd week of year), and 120 to 140 (50% credible interval [CrI], 95% CrI: 97 to 170) weekly infections per 10,000 population occurred at the peak. By the end of 2016, we estimated that approximately 890,000 (95% CrI: 660,000 to 1,100,000) individuals were infected in 2016 (26%, 95% CrI: 19% to 33%, of the population infected). Utilizing multiple indicators offers the opportunity for real-time and retrospective situational awareness to support epidemic preparedness and response.

Clinical characteristics of COVID-19 in solid organ transplant recipients following COVID-19 vaccination: A multicenter case series.

BACKGROUND: Solid organ transplant recipients (SOTR) have diminished humoral immune responses to COVID-19 vaccination and higher rates of COVID-19 vaccine breakthrough infection than the general population. Little is known about COVID-19 disease severity in SOTR with COVID-19 vaccine breakthrough infections. METHODS: Between 4/7/21 and 6/21/21, we requested case reports via the Emerging Infections Network (EIN) listserv of SARS-CoV-2 infection following COVID-19 vaccination in SOTR. Online data collection included patient demographics, dates of COVID-19 vaccine administration, and clinical data related to COVID-19. We performed a descriptive analysis of patient factors and evaluated variables contributing to critical disease or need for hospitalization. RESULTS: Sixty-six cases of SARS-CoV-2 infection after vaccination in SOTR were collected. COVID-19 occurred after the second vaccine dose in 52 (78.8%) cases, of which 43 (82.7%) occurred ≥14 days post-vaccination. There were six deaths, three occurring in fully vaccinated individuals (7.0%, n = 3/43). There was no difference in the percentage of patients who recovered from COVID-19 (70.7% vs. 72.2%, p = .90) among fully and partially vaccinated individuals. We did not identify any differences in hospitalization (60.5% vs. 55.6%, p = .72) or critical disease (20.9% vs. 33.3%, p = .30) among those who were fully versus partially vaccinated. CONCLUSIONS: SOTR vaccinated against COVID-19 can still develop severe, and even critical, COVID-19 disease. Two doses of mRNA COVID-19 vaccine may be insufficient to protect against severe disease and mortality in SOTR. Future studies to define correlates of protection in SOTR are needed.

The Role of Endotoxin in Sterile Inflammation After Implanted Acellular Dermal Matrix: Red Breast Syndrome Explained?

BACKGROUND: Red breast syndrome (RBS) is a noninfectious erythema associated with acellular dermal matrix (ADM). The underlying cause remains unknown despite multiple suggested etiologies. No similar presentations to RBS have been reported in other anatomic regions. OBJECTIVES: The authors sought to describe and identify a common etiology for ADM-associated sterile inflammation in the breast and upper extremity. METHODS: A retrospective review of medical complaints reported to MTF Biologics (Edison, NJ) from July 1, 2017 to January 3, 2018 was performed. Inventory samples were tested for endotoxin content in endotoxin units (eu) via the Limulus Amebocyte Lysate method to determine a common etiology for sterile inflammation. RESULTS: Cases of RBS and upper extremity sterile inflammation, "red hand syndrome," are presented. Two patients developed RBS following implantation of ADM from the same donor; associated grafts in inventory had endotoxin levels of 167 eu and 320 eu per graft, respectively. Two patients developed red hand syndrome after joint arthroplasty with ADM from another donor; associated graft in inventory showed an endotoxin level of 1282 eu. Cultures were obtained and negative in 3 of the 4 cases. Since endotoxin screening of ADM donor lots began in January 2018 at MTF Biologics, no cases of sterile inflammation have been reported from screened units through December 31, 2018 (RBS rate, 39/15,529 [0.25%] vs 0/18,275 [0%], P < 0.0001). CONCLUSIONS: The sterile inflammatory response in RBS and newly reported red hand syndrome may be attributable to the presence of endotoxin in implanted ADM. Endotoxin screening has been adopted by MTF Biologics with a significant decrease in reported reactions.

Evaluation of the National Healthcare Safety Network Hemovigilance Module for transfusion-related adverse reactions in the United States.

INTRODUCTION: The National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) collects data on the frequency, severity, and imputability of transfusion-associated adverse events. These events contribute to significant morbidity and mortality among transfusion patients. We report results from the first systematic assessment of eight attributes of the HM. MATERIALS AND METHODS: Standard methods were used to assess the HM. Evaluation data included training materials, system modification history, and facility survey information. A concordance analysis was performed using data from the Baystate Medical Center's (Springfield, MA) electronic transfusion reporting system. RESULTS: In 2016, system representativeness remained low, with 6% (277 of 4690) of acute care facilities across 43 jurisdictions enrolled in the HM. In 2016, 48% (2147 of 4453) and 89% (3969 of 4,453) of adverse reactions were reported within 30 and 90 days of the reaction date, respectively, compared to 21% (109 of 511) and 56% (284 of 511) in 2010, demonstrating improved reporting timeliness. Data quality from most reactions was adequate, with 10% (45 of 442) misclassified transfusion-associated circulatory overload reactions, and no incomplete transfusion-transmitted infection data reported from 2010 to 2013. When compared to the Baystate system to assess concordance, 43% (24 of 56) of NHSN-reported febrile reactions were captured in both systems (unweighted kappa value, 0.47; confidence interval, 0.33-0.61). CONCLUSION: Since the 2010 HM pilot, improvements have led to enhanced simplicity, timeliness, and strengthened data quality. The HM serves an important and unique role despite incomplete adoption nationwide. Facility efforts to track and prevent transfusion-associated adverse events through systems like the NHSN HM are a key step toward improving transfusion safety in the United States.

A mathematical model to describe survival among liver recipients from deceased donors with risk of transmitting infectious encephalitis pathogens.

BACKGROUND: Between 2002 and 2013, the organs of 13 deceased donors with infectious encephalitis were transplanted, causing infections in 23 recipients. As a consequence, organs from donors showing symptoms of encephalitis (increased probability of infectious encephalitis (IPIE) organs) might be declined. We had previously characterized the risk of IPIE organs using data available to most transplant teams and not requiring special diagnostic tests. If the probability of infection is low, the benefits of a transplant from a donor with suspected infectious encephalitis might outweigh the risk and could be lifesaving for some transplant candidates. METHODS: Using organ transplant data and Cox Proportional Hazards models, we determined liver donor and recipient characteristics predictive of post-transplant or waitlist survival and generated 5-year survival probability curves. We also calculated expected waiting times for an organ offer based on transplant candidate characteristics. Using a limited set of actual cases of infectious encephalitis transmission via transplant, we estimated post-transplant survival curves given an organ from an IPIE donor. RESULTS: 54% (1256) of patients registered from 2002-2006 who died or were removed from the waiting list because of deteriorated condition within 1 year could have had an at least marginal estimated benefit by accepting an IPIE liver with some probability of infection, with the odds increasing to 86% of patients if the probability of infection was low (5% or less). Additionally, 54% (1252) were removed from the waiting list prior to their estimated waiting time for a non-IPIE liver and could have benefited from an IPIE liver. CONCLUSION: Improved allocation and utilization of IPIE livers could be achieved by evaluating the patient-specific trade-offs between (a) accepting an IPIE liver and (b) remaining on the waitlist and accepting a non-IPIE liver after the estimated waiting time.

Diagnoses and ordering practices driving blood demand for treatment of anemia in Tanzania.

BACKGROUND: Resource-limited countries in Africa experience blood shortages. Understanding clinical drivers of blood demand can inform strategies to increase blood availability. STUDY DESIGN AND METHODS: From a national representative sample of 42 hospitals in Tanzania, patient records and requests for whole blood (WB) and red blood cells (RBCs) to treat anemia were analyzed using data collected prospectively from June through September 2013. Abstracted data included cause of anemia, number of requested units, clinical signs, and pretransfusion hemoglobin (Hb) levels. Weighted projections of nationwide drivers of blood demand for the year, 2013, were calculated. Mean posttransfusion Hb levels were estimated, and blood requests were assessed for clinical appropriateness. RESULTS: Malaria was the leading driver of blood demand for anemia among children, accounting for 67% (55,949 units; standard deviation [SD], 1911 units) of projected units requested for children in 2013. Maternal hemorrhage was the leading driver of blood demand for anemia among adults, accounting for 21% (31,321 units; SD, 963 units) of projected units requested. Seventeen percent (26,133 units; SD, 1013 units) of projected requested units were deemed inappropriate. Adults with severe anemia had a mean Hb level of 3.7 g/dL and a mean of 1.6 WB or RBC units per request, resulting in an estimated mean posttransfusion Hb level of 5.3 g/dL. CONCLUSIONS: Strategies to prevent and treat underlying causes of anemia and decrease inappropriate blood requests will likely increase blood availability. Restrictive blood ordering practices seen in adults with severe anemia suggests undertreatment of anemia and may result in an underestimation of the national blood demand.

Assessment of risk for transplant-transmissible infectious encephalitis among deceased organ donors.

BACKGROUND: There were 13 documented clusters of infectious encephalitis transmission via organ transplant from deceased donors to recipients during 2002-2013. Hence, organs from donors diagnosed with encephalitis are often declined because of concerns about the possibility of infection, given that there is no quick and simple test to detect causes of infectious encephalitis. METHODS: We constructed a database containing cases of infectious and non-infectious encephalitis. Using statistical imputation, cross-validation, and regression techniques, we determined deceased organ donor characteristics, including demographics, signs, symptoms, physical exam, and laboratory findings, predictive of infectious vs non-infectious encephalitis, and developed a calculator which assesses the risk of infection. RESULTS: Using up to 12 predictive patient characteristics (with a minimum of 3, depending on what information is available), the calculator provides the probability that a donor may have infectious vs non-infectious encephalitis, improving the prediction accuracy over current practices. These characteristics include gender, fever, immunocompromised state (other than HIV), cerebrospinal fluid elevation, altered mental status, psychiatric features, cranial nerve abnormality, meningeal signs, focal motor weakness, Babinski's sign, movement disorder, and sensory abnormalities. CONCLUSION: In the absence of definitive diagnostic testing in a potential organ donor, infectious encephalitis can be predicted with a risk score. The risk calculator presented in this paper represents a prototype, establishing a framework that can be expanded to other infectious diseases transmissible through solid organ transplantation.

Modes of Transmission of Zika Virus.

For >60 years, Zika virus (ZIKV) has been recognized as an arthropod-borne virus with Aedes species mosquitoes as the primary vector. However in the past 10 years, multiple alternative routes of ZIKV transmission have been identified. We review the available data on vector and non-vector-borne modes of transmission and interventions undertaken, to date, to reduce the risk of human infection through these routes. Although much has been learned during the outbreak in the Americas on the underlying mechanisms and pathogenesis of non-vector-borne ZIKV infections, significant gaps remain in our understanding of the relative incidence of, and risk from, these modes compared to mosquito transmission. Additional research is urgently needed on the risk, pathogenesis, and effectiveness of measures to mitigate non-vector-borne ZIKV transmission.

Mycoplasma hominis Infections Transmitted Through Amniotic Tissue Product.

Background: Mycoplasma hominis is a commensal genitourinary tract organism that can cause infections outside the genitourinary tract. We investigated a cluster of M. hominis surgical site infections in patients who underwent spine surgery, all associated with amniotic tissue linked to a common donor. Methods: Laboratory tests of tissue product from the donor, including culture, quantitative real-time polymerase chain reaction (qPCR), and whole-genome sequencing were performed. Use of this amniotic tissue product was reviewed. A multistate investigation to identify additional cases and locate any unused products was conducted. Results: Twenty-seven tissue product vials from a donor were distributed to facilities in 7 states; at least 20 vials from this donor were used in 14 patients. Of these, 4 of 14 (29%) developed surgical site infections, including 2 M. hominis infections. Mycoplasma hominis was detected by culture and qPCR in 2 unused vials from the donor. Sequencing indicated >99% similarity between patient and unopened vial isolates. For 5 of 27 (19%) vials, the final disposition could not be confirmed. Conclusions: Mycoplasma hominis was transmitted through amniotic tissue from a single donor to 2 recipients. Current routine donor screening and product testing does not detect all potential pathogens. Clinicians should be aware that M. hominis can cause surgical site infections, and may not be detected by routine clinical cultures. The lack of a standardized system to track tissue products in healthcare facilities limits the ability of public health agencies to respond to outbreaks and investigate other adverse events associated with these products.

Use of Blood Donor Screening Data to Estimate Zika Virus Incidence, Puerto Rico, April-August 2016.

Puerto Rico has been heavily impacted by Zika virus, a mosquitoborne flavivirus that emerged in the Americas during 2015. Although most persons with Zika virus show no symptoms, the virus can cause neurologic and other complications, including fetal microcephaly. Local Zika virus transmission in Puerto Rico has been reported since December 2015. To prevent transfusion-associated transmission, local blood collection ceased in March 2016 but resumed in April 2016 after Zika virus screening of blood donations became available. Using data from screening of blood donations collected by the 2 largest blood centers in Puerto Rico during April 3-August 12, 2016, and assuming a 9.9-day duration of viremia, we estimated that 469,321 persons in Puerto Rico were infected during this period, for an estimated cumulative incidence of 12.9%. Results from blood donation screening during arboviral outbreaks can supplement routine clinical and surveillance data for improved targeting of prevention efforts.

Three Cases of Neurologic Syndrome Caused by Donor-Derived Microsporidiosis.

In April 2014, a kidney transplant recipient in the United States experienced headache, diplopia, and confusion, followed by neurologic decline and death. An investigation to evaluate the possibility of donor-derived infection determined that 3 patients had received 4 organs (kidney, liver, heart/kidney) from the same donor. The liver recipient experienced tremor and gait instability; the heart/kidney and contralateral kidney recipients were hospitalized with encephalitis. None experienced gastrointestinal symptoms. Encephalitozoon cuniculi was detected by tissue PCR in the central nervous system of the deceased kidney recipient and in renal allograft tissue from both kidney recipients. Urine PCR was positive for E. cuniculi in the 2 surviving recipients. Donor serum was positive for E. cuniculi antibodies. E. cuniculi was transmitted to 3 recipients from 1 donor. This rare presentation of disseminated disease resulted in diagnostic delays. Clinicians should consider donor-derived microsporidial infection in organ recipients with unexplained encephalitis, even when gastrointestinal manifestations are absent.

Transmission of Hepatitis A Virus through Combined Liver-Small Intestine-Pancreas Transplantation.

Although transmission of hepatitis A virus (HAV) through blood transfusion has been documented, transmission through organ transplantation has not been reported. In August 2015, state health officials in Texas, USA, were notified of 2 home health nurses with HAV infection whose only common exposure was a child who had undergone multi-visceral organ transplantation 9 months earlier. Specimens from the nurses, organ donor, and all organ recipients were tested and medical records reviewed to determine a possible infection source. Identical HAV RNA sequences were detected from the serum of both nurses and the organ donor, as well as from the multi-visceral organ recipient's serum and feces; this recipient's posttransplant liver and intestine biopsy specimens also had detectable virus. The other organ recipients tested negative for HAV RNA. Vaccination of the donor might have prevented infection in the recipient and subsequent transmission to the healthcare workers.

Cost projections for implementation of safety interventions to prevent transfusion-transmitted Zika virus infection in the United States.

BACKGROUND: In August 2016, the Food and Drug Administration advised US blood centers to screen all whole blood and apheresis donations for Zika virus (ZIKV) with an individual-donor nucleic acid test (ID-NAT) or to use approved pathogen reduction technology (PRT). The cost of implementing this guidance nationally has not been assessed. STUDY DESIGN AND METHODS: Scenarios were constructed to characterize approaches to ZIKV screening, including universal ID-NAT, risk-based seasonal allowance of minipool (MP) NAT by state, and universal MP-NAT. Data from the 2015 National Blood Collection and Utilization Survey (NBCUS) were used to characterize the number of donations nationally and by state. For each scenario, the estimated cost per donor ($3-$9 for MP-NAT, $7-$13 for ID-NAT) was multiplied by the estimated number of relevant donations from the NBCUS. Cost of PRT was calculated by multiplying the cost per unit ($50-$125) by the number of units approved for PRT. Prediction intervals for costs were generated using Monte Carlo simulation methods. RESULTS: Screening all donations in the 50 states and DC for ZIKV by ID-NAT would cost $137 million (95% confidence interval [CI], $109-$167) annually. Allowing seasonal MP-NAT in states with lower ZIKV risk could reduce NAT screening costs by 18% to 25%. Application of PRT to all platelet (PLT) and plasma units would cost $213 million (95% CI, $156-$304). CONCLUSION: Universal ID-NAT screening for ZIKV will cost US blood centers more than $100 million annually. The high cost of PRT for apheresis PLTs and plasma could be mitigated if, once validated, testing for transfusion transmissible pathogens could be eliminated.

Continued decline in blood collection and transfusion in the United States-2015.

BACKGROUND: In 2011 and 2013, the National Blood Collection and Utilization Survey (NBCUS) revealed declines in blood collection and transfusion in the United States. The objective of this study was to describe blood services in 2015. STUDY DESIGN AND METHODS: The 2015 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated. RESULTS: Response rates for the 2015 NBCUS were 78.4% for blood collection centers and 73.9% for transfusing hospitals. In 2015, 12,591,000 units of red blood cells (RBCs) (95% confidence interval [CI], 11,985,000-13,197,000 units of RBCs) were collected, and 11,349,000 (95% CI, 10,592,000-11,747,000) were transfused, representing declines since 2013 of 11.6% and 13.9%, respectively. Total platelet units distributed (2,436,000; 95% CI, 2,230,000-2,642,000) and transfused (1,983,000; 95% CI, 1,816,000 = 2,151,000) declined by 0.5% and 13.1%, respectively, since 2013. Plasma distributions (3,714,000; 95% CI, 3,306,000-4,121,000) and transfusions (2,727,000; 95% CI, 2,594,000-2,859,000) in 2015 declined since 2013. The median price paid per unit in 2015-$211 for leukocyte-reduced RBCs, $524 for apheresis platelets, and $54 for fresh frozen plasma-was less for all components than in 2013. CONCLUSIONS: The 2015 NBCUS findings suggest that continued declines in demand for blood products resulted in fewer units collected and distributed Maintaining a blood inventory sufficient to meet routine and emergent demands will require further monitoring and understanding of these trends.

St. Louis encephalitis virus possibly transmitted through blood transfusion-Arizona, 2015.

BACKGROUND: St. Louis encephalitis virus is a mosquito-borne flavivirus that infrequently causes epidemic central nervous system infections. In the United States, blood donors are not screened for St. Louis encephalitis virus infection, and transmission through blood transfusion has not been reported. During September 2015, St. Louis encephalitis virus infection was confirmed in an Arizona kidney transplant recipient. An investigation was initiated to determine the infection source. STUDY DESIGN AND METHODS: The patient was interviewed, and medical records were reviewed. To determine the likelihood of mosquito-borne infection, mosquito surveillance data collected at patient and blood donor residences in timeframes consistent with their possible exposure periods were reviewed. To investigate other routes of exposure, organ and blood donor and recipient specimens were obtained and tested for evidence of St. Louis encephalitis virus infection. RESULTS: The patient presented with symptoms of central nervous system infection. Recent St. Louis encephalitis virus infection was serologically confirmed. The organ donor and three other organ recipients showed no laboratory or clinical evidence of St. Louis encephalitis virus infection. Among four donors of blood products received by the patient via transfusion, one donor had a serologically confirmed, recent St. Louis encephalitis virus infection. Exposure to an infected mosquito was unlikely based on the patient's minimal outdoor exposure. In addition, no St. Louis encephalitis virus-infected mosquito pools were identified around the patient's residence. CONCLUSION: This investigation provides evidence of the first reported possible case of St. Louis encephalitis virus transmission through blood product transfusion. Health care providers and public health professionals should maintain heightened awareness for St. Louis encephalitis virus transmission through blood transfusion in settings where outbreaks are identified.

Solid Organ Transplant-Transmitted Tuberculosis Linked to a Community Outbreak - California, 2015.

In the spring of 2015, a local health department (LHD) in county A notified the California Department of Public Health (CDPH) about three adults with close ties to one another and a congregate community site who had received diagnoses of tuberculosis (TB) disease within a 3-month period. Subsequent review revealed matching TB genotypes indicating that the cases were likely part of a chain of TB transmission. Only three TB cases in California in the preceding 2 years shared this same genotype. One of those three previous cases occurred in a lung-transplant recipient who had no identified epidemiologic links to the outbreak. CDPH, multiple LHDs, and CDC conducted an investigation and determined that the lung-transplant donor (patient 1) was epidemiologically linked to the three outbreak cases and had a tuberculin skin test (TST) conversion detected in 2012 upon reentry at a local jail. Three other solid organ recipients from this donor were identified; none had developed TB disease. This investigation suggests that review of organ donors' medical records from high-risk environments, such as jails, might reveal additional information about TB risk. The evaluation of TB in organ recipients could include genotyping analysis (1) and coordination among local, state, and national partners to evaluate the potential for donor-derived TB.